A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma

NCT ID: NCT00785083

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma, adrenergic beta agonists, multiple sclerosis, pulmonary function tests, forced expiratory volume

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

FTY720

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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FTY720

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Forced Expiratory Volume in 1 second of at least 60%
* History of asthma for at least 6 months
* Current use of short-acting beta agonists, inhaled long-acting beta agonists and inhaled corticosteroids (up to a specified dose)

Exclusion Criteria

* History of lung disease other than asthma
* Smokers
* Use of inhaled corticosteroid above specified dose
* Use of oral beta agonists or corticosteroids or other asthma medications
* Hypersensitivity to the drug
* Respiratory tract infections within 1 month of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis Investigator Site

Locations

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Novartis Investigator Site

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Boulton C, David OJ, Meiser K, Schmouder R. Tolerability and Pulmonary Pharmacodynamic Effects During Treatment Initiation of Once-Daily Oral Fingolimod in Subjects With Moderate Asthma. Clin Pharmacol Drug Dev. 2013 Jan;2(1):2-10. doi: 10.1002/cpdd.4. Epub 2013 Mar 4.

Reference Type RESULT
PMID: 27121555 (View on PubMed)

Izquierdo G, O'Connor P, Montalban X, von Rosenstiel P, Cremer M, de Vera A, Sfikas N, Francis G, Radue EW, Kappos L. Five-year results from a phase 2 study of oral fingolimod in relapsing multiple sclerosis. Mult Scler. 2014 Jun;20(7):877-81. doi: 10.1177/1352458513513059. Epub 2013 Nov 30.

Reference Type DERIVED
PMID: 24293455 (View on PubMed)

Other Identifiers

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CFTY720D2102

Identifier Type: -

Identifier Source: org_study_id